U.S. FDA Grants Priority Review to Simeprevir (TMC435) for Combination Treatment of Genotype 1
Cinnamon Girl said
May 14, 2013
Puzzling, isn`t it. I can`t see why it`s being given Priority Review either.
52baddog said
May 14, 2013
Hi Malcolm:
From what they told us at the screening was that they are only talking patients who have not been treated before, and don't have
cirrhosis.
Biggyb said
May 14, 2013
I have no idea Malcolm,, when they take the peg out, that's when it interest's me.
mallani said
May 14, 2013
Hi Jill,
I've poured over the results for Quest-1, Quest-2 and Promise Trials and wonder what I'm missing. Simeprevir has an advantage in being a single pill, but still needs to be used with Peg and Riba. As a second generation NS-3/4A inhibitor, I expected better results than those for Incivek and Victrelis. The same old problems appear and the difference in results for Interleukin 28B variants is more striking. The TT alleles do very poorly. The SVR rates are highly dependent on the Fibrosis score, which is not what we are looking for. The side effects are not well documented but fatigue and rash seem common.
Can anyone explain why this drug deserves Priority Review?
Cinnamon Girl said
May 13, 2013
U.S. FDA Grants Priority Review to Simeprevir (TMC435) for Combination Treatment of Genotype 1 Chronic Hepatitis C
RARITAN, N.J., May 13, 2013 /PRNewswire/ -- Janssen Research & Development announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the New Drug Application (NDA) for simeprevir (TMC435), an investigational NS3/4A protease inhibitor administered as a 150 mg capsule once daily with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease.
Puzzling, isn`t it. I can`t see why it`s being given Priority Review either.
Hi Malcolm:
From what they told us at the screening was that they are only talking patients who have not been treated before, and don't have
cirrhosis.
I have no idea Malcolm,, when they take the peg out, that's when it interest's me.
Hi Jill,
I've poured over the results for Quest-1, Quest-2 and Promise Trials and wonder what I'm missing. Simeprevir has an advantage in being a single pill, but still needs to be used with Peg and Riba. As a second generation NS-3/4A inhibitor, I expected better results than those for Incivek and Victrelis. The same old problems appear and the difference in results for Interleukin 28B variants is more striking. The TT alleles do very poorly. The SVR rates are highly dependent on the Fibrosis score, which is not what we are looking for. The side effects are not well documented but fatigue and rash seem common.
Can anyone explain why this drug deserves Priority Review?
U.S. FDA Grants Priority Review to Simeprevir (TMC435) for Combination Treatment of Genotype 1 Chronic Hepatitis C
RARITAN, N.J., May 13, 2013 /PRNewswire/ -- Janssen Research & Development announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the New Drug Application (NDA) for simeprevir (TMC435), an investigational NS3/4A protease inhibitor administered as a 150 mg capsule once daily with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease.
Full news release...
http://www.prnewswire.com/news-releases/us-fda-grants-priority-review-to-simeprevir-tmc435-for-combination-treatment-of-genotype-1-chronic-hepatitis-c-207169391.html